TFL Gallery / t-eff-adas-wk24-female

t-eff-adas-wk24-female

Discovered on disk but not present in site/config.json.

This display exists on disk but is not registered in site/config.json, so it has no reviewed metadata.

Slug: t-eff-adas-wk24-female
Regulatory ID: —
Type: Table
E3 position: unassigned
Status: built
Current iteration: v001
Datasets: —
Evidence: not yet generated
Requirements: —
Used in: Clinical Study Report Table 14.2.9
Post-Text Display Package Table 14.2.9
Abbreviated Clinical Study Report (ICH E3) Table 14.2.9

Generated by the same pipeline run that wrote the ARD and the HTML above, from the same rendered cells; the short hash is the manifest's record of the file.

t-eff-adas-wk24-female · post_text variant · study CDISCPILOT01 · data cut-off 2015-02-17

	Placebo (N=46)	Xanomeline Low Dose (N=47)	Xanomeline High Dose (N=35)
ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF
Study CDISCPILOT01 — Efficacy Analysis Set, female subjects
Baseline
n	46	47	35
Mean (SD)	25.1 (11.25)	25.2 (12.15)	21.8 (12.54)
Median (Range)	23.5 (5;51)	21.0 (5;55)	18.0 (5;57)
Week 24
n	46	47	35
Mean (SD)	28.1 (13.70)	26.9 (12.09)	22.9 (12.84)
Median (Range)	24.0 (8;59)	25.0 (8;62)	19.0 (4;62)
Change from baseline
n	46	47	35
Mean (SD)	3.0 (5.57)	1.7 (5.54)	1.1 (4.77)
Median (Range)	3.0 (-8;16)	2.0 (-11;17)	0.0 (-7;13)
Statistical comparison of the change from baseline
p-value (dose response) [1][2]			0.094
p-value (Xanomeline - Placebo) [1][3]		0.160	0.135
Difference of LS means (SE)		-1.6 (1.10)	-1.8 (1.20)
95% CI		(-3.7;0.6)	(-4.2;0.6)
p-value (Xanomeline High - Xanomeline Low) [1][3]			0.843
Difference of LS means (SE)			-0.2 (1.21)
95% CI			(-2.6;2.2)
[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate.
[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable.
[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons.
Missing post-baseline values are imputed by last observation carried forward, over assessments assigned to visit windows (CDISCPILOT01 statistical analysis plan, sections 8.1 and 8.2).
Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them.
CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package.
Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.09. Data cut-off: 2015-02-17.
open.csr display t-eff-adas-wk24-female (post_text variant); generated from the committed ARD.

Rendered from outputs/t-eff-adas-wk24-female/v001/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
population	TRTP	Placebo	—	—	USUBJID	—	population	N	N	—	—	46
population	TRTP	Xanomeline High Dose	—	—	USUBJID	—	population	N	N	—	—	35
population	TRTP	Xanomeline Low Dose	—	—	USUBJID	—	population	N	N	—	—	47
summary	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	46
summary	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	25.0787106446777
summary	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	11.2459752799396
summary	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	23.5
summary	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	15
summary	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	31
summary	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	51
summary	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	46
summary	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	28.0892053973013
summary	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.6962511032725
summary	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	24
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	19
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	33
summary	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	8
summary	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	59
summary	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	46
summary	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	3.01049475262369
summary	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	5.57339654835608
summary	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	3
summary	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	0
summary	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	6
summary	TRTP	Placebo	—	—	CHG	—	continuous	min	Min	—	—	-8
summary	TRTP	Placebo	—	—	CHG	—	continuous	max	Max	—	—	16
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	N	N	—	—	35
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	21.8285714285714
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	12.5381434836584
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	18
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	13
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	27
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	57
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	35
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	22.8893267651888
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.8431127378602
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	19
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	16
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	27
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	4
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	61.551724137931
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	35
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.06075533661741
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.77368047085683
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	0
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-2
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	4.55172413793103
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-6.75862068965517
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	13
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	47
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	25.2399119589142
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	12.1471869894876
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	21
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	17
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	35
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	55
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	47
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	26.8914159941306
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.0850160539409
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	25
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	20
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	36
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	8
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	62
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	47
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.65150403521643
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	5.54250789697819
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	2
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-1
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	5
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-11
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	17
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	pvalue	pvalue	—	—	0.093767790534555
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	n_model	n_model	—	—	128
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	-1.56138863976059
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.1036134153909
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.159853777935369
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-3.7476383155928
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	0.624861036071612
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	128
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	-1.8017562698781
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.19546161553639
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.134534891493819
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-4.16995652278147
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	0.566443983025261
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	128
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	estimate	estimate	—	—	-0.240367630117509
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	se	se	—	—	1.21021554959204
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	pvalue	pvalue	—	—	0.842917264147257
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	lcl	lcl	—	—	-2.63779531274996
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	ucl	ucl	—	—	2.15706005251494
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	n_model	n_model	—	—	128

95 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-08-27T03:41:23Z
Spec hash: sha256:9b0ea9bafb1a8b2c8ab857d150ef9ff6aacd4d1bd2316aadbc1f992cc73f2675
Display hash: sha256:97fcb12be723cea99687c77836a58106fdbeeb659562fbee6d93914ec4b8b55c
ARD file: outputs/t-eff-adas-wk24-female/v001/ard.json
ARD hash: sha256:a6fddf0761ff7c01dc414592acf1f3a31cadb57a523331c3a2ee90606c515dfd

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:6534192e6ae2a8789015148d2068ecdd8421791ea6d7f9cc307fef1db97945f9
adqsadas	12463	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:0f3e481baf734dc3e5ce7373d255269c2285400ff5bee77be525d832bade80cf

Environment

R 4.3.3 · Darwin 23.6.0 · cards 0.6.1 · cardx 0.2.5 · gtsummary 2.3.0 · gt 1.0.0 · dplyr 1.1.4 · pharmaverseadam 1.1.0 · jsonlite 2.0.0 · yaml 2.3.10 · digest 0.6.37

library/tfl/t-eff-adas-wk24-female/analysis.yaml

id: t-eff-adas-wk24-female
title: "ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF"
regulatory_id: EFT06
type: table
dataset: adqsadas
analysis_set: efficacy
denominator: adsl
sources: phuse
group:
  - TRTP
total: false
analyses:
  - name: population
    method: continuous
    custom: population_n
    label: "Subjects in the analysis population"
    filter: "PARAMCD == 'ACTOT' & SEX == 'F'"
  - name: summary
    method: continuous
    label: "ADAS-Cog (11) total score at baseline, at Week 24, and its change"
    variables: [BASE, AVAL, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & SEX == 'F' & AVISIT == 'Week 24'"
  - name: ancova
    method: continuous
    custom: ancova_change
    label: "ANCOVA of the change from baseline to Week 24"
    variables: [CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & SEX == 'F' & AVISIT == 'Week 24'"
    response: CHG
    covariates: [BASE]
    factors: [SITEGR1]
    treatment: TRTP
    treatment_levels: ["Placebo", "Xanomeline Low Dose", "Xanomeline High Dose"]
    dose: TRTPN
    conf_level: 0.95
    contrasts:
      - { name: dose_response, type: dose, column: "Xanomeline High Dose" }
      - { name: xan_vs_placebo, type: pairwise, test: "Xanomeline Low Dose",
          reference: "Placebo", column: "Xanomeline Low Dose" }
      - { name: xan_vs_placebo, type: pairwise, test: "Xanomeline High Dose",
          reference: "Placebo", column: "Xanomeline High Dose" }
      - { name: high_vs_low, type: pairwise, test: "Xanomeline High Dose",
          reference: "Xanomeline Low Dose", column: "Xanomeline High Dose" }

library/tfl/t-eff-adas-wk24-female/display.yaml

id: t-eff-adas-wk24-female
title: "ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF"
study: CDISCPILOT01
population_label: "Efficacy Analysis Set, female subjects"
cutoff: "2015-02-17"
source: "Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.09. Data cut-off: 2015-02-17."
footnotes:
  - "[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate."
  - "[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable."
  - "[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons."
  - "Missing post-baseline values are imputed by last observation carried forward, over assessments assigned to visit windows (CDISCPILOT01 statistical analysis plan, sections 8.1 and 8.2)."
  - "Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them."
  - "CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package."
columns:
  order: ["Placebo", "Xanomeline Low Dose", "Xanomeline High Dose"]
format:
  mean_sd: "{mean} ({sd})"
  median_range: "{median} ({min};{max})"
  est_se: "{estimate} ({se})"
  ci: "({lcl};{ucl})"
  p_value: "{pvalue}"
  digits:
    mean: 1
    sd: 2
    median: 1
    min: 0
    max: 0
    estimate: 1
    se: 2
    lcl: 1
    ucl: 1
    pvalue: 3
rows:
  - { label: "Baseline", section: true }
  - { analysis: summary, variable: BASE, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: BASE, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: BASE, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Week 24", section: true }
  - { analysis: summary, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Change from baseline", section: true }
  - { analysis: summary, variable: CHG, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: CHG, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: CHG, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Statistical comparison of the change from baseline", section: true }
  - { analysis: ancova, variable: CHG, level: dose_response, pattern: p_value,
      label: "p-value (dose response) [1][2]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: p_value,
      label: "p-value (Xanomeline - Placebo) [1][3]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: est_se,
      label: "Difference of LS means (SE)", indent: 2 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: ci,
      label: "95% CI", indent: 2 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: p_value,
      label: "p-value (Xanomeline High - Xanomeline Low) [1][3]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: est_se,
      label: "Difference of LS means (SE)", indent: 2 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: ci,
      label: "95% CI", indent: 2 }
variants:
  post_text: {}

library/tfl/t-eff-adas-wk24-female/custom.R

# Display-specific statistics (contract section 2).
#
# Both functions are thin wrappers: the statistics themselves live in
# {opencsr} so that the seven ADAS-Cog displays share one tested
# implementation, and every model term is declared in this display's
# analysis.yaml rather than written in code.

ancova_change <- function(data, spec, denominator = NULL) {
  opencsr::ard_ancova(data, spec, denominator)
}

population_n <- function(data, spec, denominator = NULL) {
  opencsr::ard_population_n(data, spec, denominator)
}

Every iteration is kept: outputs/t-eff-adas-wk24-female/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.